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BGF Consulting provides

Variety of training

cGMP/Quality Assurance Controls

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BGF knows "Nobody cares how much you know until they know how much you care", BGF your friendly qualified consultant.

Click Here For Free Consultation

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Schedule Now

Reserve your expert consultant today at NO COST

Consultation

$399

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Don't wait too late!

Solutions cost less than problems.

Remember!

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BGF is a Private-Public Company

Tax incentives anyone?

Tax incentives anyone?

Tax incentives anyone?

Tax incentives anyone?

Tax incentives anyone?

Contact US

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REGULATORY TRAINING

  • GOOD MANUFACTURING PRACTICES (GMP) TRAINING
  • INSPECTION READINESS
  • CORRECTIVE AND PREVENTATIVE ACTION (CAPA)
  • PRESCRIPTION DRUG MARKETING ACT (PDMA) & SAMPLING HANDLING

AUDITING SOLUTIONS

  • SUPPLIER AUDITING
  • SERVICE PROVIDER AUDITING
  • INTERNAL AUDITING HELP
  • COMPLIANCE GAP ANALYSIS AND REMEDIATION PLANS

VALIDATION SERVICES

  • VALIDATION MASTER PLAN DEVELOPMENT
  • EQUIPMENT VALIDATION
  • PROCESS VALIDATION ASSISTANCE 
  • FACILITY AND UTILITY VALIDATION

REGULATORY AFFAIRS

  • DEVELOPMENT OF REGULATORY STRATEGY
  • PREPARATION AND REVIEW OF REGULATORY FILINGS
  • REGULATORY INTERACTION SUPPORT
  • MANUFACTURING PROCESS EVALUATION AND OPTIMIZATION

BGF Wants To Know… “What’s Your Problem?”

Are you on the “Top 10 List of F.D.A failures” due to these reasons? Which one of these Top 10 reasons best fits your situation? Plain & Simple…

  1. Are your regulatory practices not in official writing, or not being fully followed?
  2. Are you under investigation for compliance discrepancies?
  3. Is there an absence of written compliance procedures at your business?
  4. Do you lack scientifically sound laboratory controls?
  5. Do you have control procedures in place to monitor and validate performance?
  6. Are your written compliance procedures not officially established or followed?
  7. Are you having trouble with the calibration or inspection of your equipment?
  8. Do you need training or help operating along the lines of good manufacturing practices?
  9. Are you having issues cleaning, sanitizing, or maintaining your equipment?
  10. Are your standard operating procedures not being followed or documented properly?

BGF is a group of consultants with direct industry experience, who provide regulatory compliance and project management expertise, to assist organizations in driving projects to completion, and preventing and remediating compliance challenges. We help organizations understand current regulatory expectations and provides common sense, stream lined solutions that can be efficiently sustained.

Our consultants provide hands-on assistance, project management and regulatory strategies to drive projects to an efficient and compliant close. The bandwith of the multi-disciplinary team enables us to provide expertise in validation, regulatory compliance and approvals, quality systems and GMPs, analytical and microbiological analysis, and process development and improvement.

We operate domestically and internationally with companies operating within regulated environments, such as pharmaceutical, medical device, biotechnology, food, and nutritional companies.